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Sustained release topiramate

a technology of topiramate and sucralose, which is applied in the field of sucralose, can solve the problems of manic depression, higher incidence of bipolar affective disorder, and inability to maintain the effect of preventing the degradation or growth of contaminants, and facilitating manufacturing

Inactive Publication Date: 2003-04-17
R T ALAMO VENTURES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009] Poor compliance with taking antipsychotics has been reported in up to fifty percent of people with psychotic disorders (Tatton and Creed, Negative symptoms of schizophrenia and compliance with medication, Schizophr. Bull. 27:149-155, 2001). Poor compliance by patients has been cited as a major reason for relapse in the treatment of these disorders (Moore, et al., Compliance and psychological reactance in schizophrenia, Br. J. Clin. Psycol. 39:287-295, 2000). When using topiramate, the repeated dosages necessary with the current formulations may make patient compliance difficult. Simplification of medicine-taking behavior has been shown to be successful in addressing patient compliance problems. The sustained-release formulations of topiramate of the present invention will simplify the patient's medicine-taking. They will need to be administered less frequently and, therefore, permit better patient compliance.

Problems solved by technology

Any person can develop manic depression, however, studies indicate that highly creative, sensitive people, people tending to be perfectionists and high achievers, have a higher incidence of Bipolar Affective Disorder.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0093] This example illustrates a method of administering a mania-alleviating amount of topiramate in a sustained-release formulation.

[0094] A dose of topiramate (e.g., 400 mg) in a sustained-release formulation is administered to the patient for at least four to six weeks. The Patient is monitored for a decrease in symptoms of mania as measured by the AMDS Mania-Depression Scale (Woggen, B., Int. Pharmacopsychiat., 14:228-242, 1979; Woggen, B., Int. Pharmacopsychiat., 14:325-337, 1979) or the Manic State Rating Scale (MSRS; Beigel, A., et al., Arch. Gen. Psychiat. 25:256-262, 1971; Cookson, J. C., et al., Neuropharmacology 18:1011-1013, 1979). The AMDS and MSRS will show clinical improvement in the symptoms of mania.

example 2

[0095] This example illustrates a method of administering a mania-alleviating amount of topiramate in a sustained-release formulation.

[0096] This experiment utilizes two test groups of patients. All of the patients are suffering from mania. The study is a randomized, double-blind, placebo controlled design. One treatment group receives a dose (e.g., 400 mg) of sustained-release topiramate, the other group receives a placebo. A dose of placebo or topiramate (e.g., 400 mg) in a sustained-release formulation is administered once a day to the patients for at least 4 weeks by the patients or medical professional. Efficacy is measured by the AMDS Mania-Depression Scale (Woggen, B., Int. Pharmacopsychiat., 14:228-242, 1979; Woggen, B., Int. Pharmacopsychiat., 14:325-337, 1979) or the Manic State Rating Scale (MSRS; Beigel, A., et al, Arch. Gen. Psychiat. 25:256-262, 1971; Cookson, J. C., et al., Neuropharmacology 18:1011-1013, 1979). Results are compared between the test group and the plac...

example 3

[0097] This example illustrates the bio-equivalency with respect to the extent of absorption of the sustained-release topiramate as compared to administration of topiramate conventional immediate release tablet when administered as multiple daily doses.

[0098] In this study two groups of twenty human subjects are given a dose of 800 mg of topiramate either as 1) a single sustained-release dose, as embodied by the present invention, 2) conventional immediate release tablets of 200 mg administered four times a day or 400 mg tablets administered twice a day. Plasma concentrations of topiramate are measured serially to define the topiramate plasma concentration-time profile by published methods including gas chromatography (Riffitts, et al., A capillary gas chromatographic assay with nitrogen phosphorus detection for the quantification of topiramate in human plasma, urine and whole blood, J. Pharm. Biomed. Anal. 19:363-371, 1999) and HPLC (Gidal and Lensmeyrer, Therapeutic monitoring of ...

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Abstract

The present invention is an improvement in the treatment of mania and depression by administering topiramate in a sustained-release formulation. The sustained-release formulation of the present invention may also be co-administered with anti-psychotics and anti-depressants.

Description

[0001] The present invention relates to the use of a sustained-release formulation of topiramate for the treatment of mania, depression and bipolar disorder.BACKGROUND OF INVENTION[0002] Manic depression involves wide mood alterations, with periods of both depression and mania. A person experiencing depression or mania may have intense mood swings and consequent changes in thinking and behavior. The term that is professionally used for this illness is Bipolar Affective Disorder. Bipolar means sharing two poles (high and low) and Affective Disorder means a disorder having to do with mood.[0003] The cause of manic depression is not known. Manic depression can send a person plunging from a high state, where one may believe one has superhuman energy and abilities, into a pit of despair, where it may seem as if the only way out is suicide. It is estimated that 1% of the population will have a manic-depressive illness. The number of manic and depressive episodes varies greatly from person...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/50A61K9/52A61K31/35A61K31/7008
CPCA61K9/2846A61K9/5026A61K31/35A61K31/7008A61K2300/00
Inventor CUTLER, NEAL R.
Owner R T ALAMO VENTURES
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